This company has registrations in United States, Saudi Arabia, Taiwan, Singapore, Australia — 5 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K250280 | SD TL Implant System | 2025-07-23 |
| US | K250063 | ARENA Star, Galaxy Star | 2025-07-10 |
| US | K241703 | SD Implant System | 2025-02-24 |
| SA | ME0000007507SFDAA00001 | Arum Screw Driver | — |
| SA | ME0000007503SFDAA00001 | Lab Analog | — |